ERYTHROMYCIN tablet film coated

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Erythromycin (UNII: 63937KV33D) (Erythromycin - UNII:63937KV33D)
Available from:
Avera McKennan Hospital
INN (International Name):
Erythromycin
Composition:
Erythromycin 250 mg
Prescription type:
PRESCRIPTION DRUG
Authorization status:
Abbreviated New Drug Application

ERYTHROMYCIN- erythromycin tablet, film coated

Avera McKennan Hospital

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ERYTHROMYCIN

TABLETS, USP

Film-coated Tablets

Rx only

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Erythromycin

Tablets and other antibacterial drugs, Erythromycin Tablets should be used only to treat or prevent

infections that are proven or strongly suspected to be caused by bacteria.

DESCRIPTION

Erythromycin Tablets, USP are an antibacterial product containing erythromycin, USP, in a unique,

nonenteric film coating for oral administration. Erythromycin Tablets are available in two strengths

containing either 250 mg or 500 mg of erythromycin base.

Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus)

and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids.

Erythromycin is a white to off-white powder, slightly soluble in water, and soluble in alcohol,

chloroform, and ether. Erythromycin is known chemically as (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*,

12R*, 13S*, 14R*)-4-[(2,6-dideoxy-3-C-methyl-3-O-methyl-??-L-ribo-hexopyranosyl)oxy]-14-ethyl-

7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-??-D-xylo -

hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione. The molecular formula is C

H NO , and the

molecular weight is 733.94. The structural formula is:

Inactive Ingredients

Colloidal silicon dioxide, croscarmellose sodium, crospovidone, D&C Red No. 30 Aluminum Lake,

hydroxypropyl cellulose, hypromellose, hydroxypropyl methylcellulose phthalate, magnesium stearate,

microcrystalline cellulose, povidone, polyethylene glycol, propylene glycol, sodium citrate, sodium

hydroxide, sorbic acid, sorbitan monooleate, talc, and titanium dioxide.

CLINICAL PHARMACOLOGY

Orally administered erythromycin base and its salts are readily absorbed in the microbiologically active

form. Interindividual variations in the absorption of erythromycin are, however, observed, and some

patients do not achieve optimal serum levels. Erythromycin is largely bound to plasma proteins. After

absorption, erythromycin diffuses readily into most body fluids. In the absence of meningeal

inflammation, low concentrations are normally achieved in the spinal fluid but the passage of the drug

across the blood-brain barrier increases in meningitis. Erythromycin crosses the placental barrier, but

fetal plasma levels are low. The drug is excreted in human milk. Erythromycin is not removed by

peritoneal dialysis or hemodialysis.

In the presence of normal hepatic function, erythromycin is concentrated in the liver and is excreted in

the bile; the effect of hepatic dysfunction on biliary excretion of erythromycin is not known. After oral

administration, less than 5% of the administered dose can be recovered in the active form in the urine.

Optimal blood levels are obtained when Erythromycin Tablets are given in the fasting state (at least 1/2

hour and preferably 2 hours before meals). Bioavailability data are available from Arbor

Pharmaceuticals.

Microbiology

Mechanism of Action

Erythromycin acts by inhibition of protein synthesis by binding 50S ribosomal subunits of susceptible

organisms. It does not affect nucleic acid synthesis.

Mechanism of Resistance

The major route of resistance is modification of the 23S rNA in the 50S ribosomal subunit to

insensitivity while efflux can also be significant.

Interactions with Other Antibiotics

Antagonism exists in vitro between erythromycin and clindamycin, lincomycin, and chloramphenicol.

Erythromycin has been shown to be active against most isolates of the following bacteria both in vitro

and in clinical infections as described in the INDICATIONS AND USAGE section.

Gram-positive Bacteria:

Corynebacterium diphtheriae

Corynebacterium minutissimum

Listeria monocytogenes

Staphylococcus aureus (resistant organisms may emerge during treatment)

Streptococcus pneumoniae

Streptococcus pyogenes

Gram-negative Bacteria:

Bordetella pertussis

Haemophilus influenzae

Legionella pneumophila

Neisseria gonorrhoeae

Other Microorganisms:

Chlamydia trachomatis

Entamoeba histolytica

Mycoplasma pneumoniae

Treponema pallidum

Ureaplasma urealyticum

The following in vitro data are available, but their clinical significance is unknown.

At least 90% of the following bacteria exhibit in vitro minimum inhibitory concentration (MIC) less than

or equal to the susceptible breakpoint for erythromycin. However, the efficacy of erythromycin in

treating clinical infections due to these bacteria has not been established in adequate and well controlled

clinical trials.

Gram-positive Bacteria:

Viridans group streptococci

Gram-negative Bacteria:

Moraxella catarrhalis

Susceptibility Test Methods

When available the clinical microbiology laboratory should provide the results of in vitro susceptibility

test results for antimicrobial drug products used in resident hospitals to the physician as periodic

reports that describe the susceptibility profile of nosocomial and community-acquired pathogens.

These reports should aid the physician in selecting an antibacterial drug product for treatment.

Dilution Techniques

Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MIC's).

These MICs provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MICs

should be determined using a standardized test method

(broth and/or agar). The MIC values should be

interpreted according to criteria provided in Table 1.

Diffusion techniques

Quantitative methods that require measurement of zone diameters can also provide reproducible

estimates of the susceptibility of bacteria to antimicrobial compounds. The zone size provides an

estimate of the susceptibility of bacteria to antimicrobial compounds. The zone size should be

determined using a standardized test method.

This procedure uses paper disks impregnated with 15

mcg erythromycin to test the susceptibility of microorganisms to erythromycin. The disc diffusion

interpretive criteria are provided in Table 1.

Table 1. In Vitro Susceptibility Test Interpretive Criteria for

Erythromycin

Minimum Inhibitory

Concentrations

(mcg/mL)

Disk Diffusion

(zone diameters in mm)

Pathogen

S

I

R

S

I

R

Staphylococcus

aureus

???0.5

???8

???23

14-22

???13

Streptococcus

pneumoniae

???0.25

???1

???21

16-20

???15

Streptococcus

pyogenes

???0.25

???1

???21

16-20

???15

A report of "Susceptible" indicates that the antimicrobial is likely to inhibit growth of the pathogen if

the antimicrobial compound reaches the concentrations at the site of infection necessary to inhibit

growth of the pathogen. A report of "Intermediate" indicates that the result should be considered

equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the

test should be repeated. This category implies possible clinical applicability in body sites where the

drug product is physiologically concentrated or in situations where high dosage of drug can be used.

1, 2

This category also provides a buffer zone which prevents small uncontrolled technical factors from

causing major discrepancies in interpretation. A report of "Resistant" indicates that the antimicrobial is

not likely to inhibit growth of the pathogen if the antimicrobial compound reaches the concentrations

usually achievable at the infection site; other therapy should be selected.

Quality Control

Standardized susceptibility test procedures require the use of laboratory controls to monitor and ensure

the accuracy and precision of supplies and reagents used in the assay, and the techniques of the

individuals performing the test.

Standard erythromycin powder should provide the following

range of MIC values noted in Table 2. For the diffusion technique using the 15 mcg disk, the criteria in

Table 2 should be achieved.

Table 2. Acceptable Quality Control Ranges for Erythromycin

QC Strain

Minimum Inhibitory

Concentrations

(mcg/mL)

Disk Diffusion

(zone diameters in

mm)

Staphylococcus aureus

ATCC 29213

0.25-1

Staphylococcus aureus

ATCC 25923

22-30

Enterococcus faecalis

ATCC 29212

Streptococcus

pneumoniae

ATCC 49619

0.03-0.12

25-30

INDICATIONS AND USAGE

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Erythromycin

Tablets, USP and other antibacterial drugs, Erythromycin Tablets, USP should be used only to treat or

prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When

culture and susceptibility information are available, they should be considered in selecting or modifying

antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may

contribute to the empiric selection of therapy.

Erythromycin Tablets, USP are indicated in the treatment of infections caused by susceptible strains of

the designated microorganisms in the diseases listed below:

Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes;

Streptococcus pneumoniae; Haemophilus influenzae (when used concomitantly with adequate doses of

sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations

ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.)

Lower respiratory tract infections of mild to moderate severity caused by Streptococcus pyogenes or

Streptococcus pneumoniae.

Listeriosis caused by Listeria monocytogenes.

Respiratory tract infections due to Mycoplasma pneumoniae.

Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or

Staphylococcus aureus (resistant staphylococci may emerge during treatment).

Pertussis (whooping cough) caused by Bordetella pertussis. Erythromycin is effective in eliminating the

1, 2, 3, 4

organism from the nasopharynx of infected individuals, rendering them noninfectious. Some clinical

studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible

individuals.

Diphtheria: Infections due to Corynebacterium diphtheriae, as an adjunct to antitoxin, to prevent

establishment of carriers and to eradicate the organism in carriers.

Erythrasma: In the treatment of infections due to Corynebacterium minutissimum.

Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only). Extraenteric amebiasis

requires treatment with other agents.

Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: Erythrocin

Lactobionate-I.V.

(erythromycin lactobionate for injection, USP) followed by erythromycin base orally, as an alternative

drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with

a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving

erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months.

Erythromycins are indicated for treatment of the following infections caused by Chlamydia trachomatis:

conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy. When

tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of

uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis.

When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of

nongonococcal urethritis caused by Ureaplasma urealyticum.

Primary syphilis caused by Treponema pallidum. Erythromycin (oral forms only) is an alternative choice

of treatment for primary syphilis in patients allergic to the penicillins. In treatment of primary syphilis,

spinal fluid should be examined before treatment and as part of the follow-up after therapy.

Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy

studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may

be effective in treating Legionnaires' Disease.

Prophylaxis

Prevention of Initial Attacks of Rheumatic Fever

Penicillin is considered by the American Heart Association to be the drug of choice in the prevention

of initial attacks of rheumatic fever (treatment of Streptococcus pyogenes infections of the upper

respiratory tract e.g., tonsillitis, or pharyngitis).

Erythromycin is indicated for the treatment of

penicillin-allergic patients. The therapeutic dose should be administered for ten days.

Prevention of Recurrent Attacks of Rheumatic Fever

Penicillin or sulfonamides are considered by the American Heart Association to be the drugs of choice

in the prevention of recurrent attacks of rheumatic fever. In patients who are allergic to penicillin and

sulfonamides, oral erythromycin is recommended by the American Heart Association in the long-term

prophylaxis of streptococcal pharyngitis (for the prevention of recurrent attacks of rheumatic fever).

CONTRAINDICATIONS

Erythromycin is contraindicated in patients with known hypersensitivity to this antibiotic.

Erythromycin is contraindicated in patients taking terfenadine, astemizole, cisapride, pimozide,

ergotamine, or dihydroergotamine. (See PRECAUTIONS - Drug Interactions.)

WARNINGS

Hepatotoxicity

There have been reports of hepatic dysfunction, including increased liver enzymes, and hepatocellular

and/or cholestatic hepatitis, with or without jaundice, occurring in patients receiving oral erythromycin

products.

QT Prolongation

Erythromycin has been associated with prolongation of the QT interval and infrequent cases of

arrhythmia. Cases of torsades de pointes have been spontaneously reported during postmarketing

surveillance in patients receiving erythromycin. Fatalities have been reported. Erythromycin should be

avoided in patients with known prolongation of the QT interval, patients with ongoing proarrhythmic

conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and

in patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol)

antiarrhythmic agents. Elderly patients may be more susceptible to drug-associated effects on the QT

interval.

Syphilis in Pregnancy

There have been reports suggesting that erythromycin does not reach the fetus in adequate

concentration to prevent congenital syphilis. Infants born to women treated during pregnancy with oral

erythromycin for early syphilis should be treated with an appropriate penicillin regimen.

Clostridium difficile Associated Diarrhea

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial

agents, including Erythromycin Tablets, and may range in severity from mild diarrhea to fatal colitis.

Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C.

difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin

producing strains of C. difficile cause increased morbidity and mortality, as these infections can be

refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients

who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD

has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to

be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic

treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Drug Interactions

Serious adverse reactions have been reported in patients taking erythromycin concomitantly with

CYP3A4 substrates. These include colchicine toxicity with colchicine; rhabdomyolysis with

simvastatin, lovastatin, and atorvastatin; and hypotension with calcium channel blockers metabolized by

CYP3A4 (e.g., verapamil, amlodipine, diltiazem) (see PRECAUTIONS - Drug Interactions).

There have been post-marketing reports of colchicine toxicity with concomitant use of erythromycin

and colchicine. This interaction is potentially life-threatening, and may occur while using both drugs at

their recommended doses (see PRECAUTIONS - Drug Interactions).

Rhabdomyolysis with or without renal impairment has been reported in seriously ill patients receiving

erythromycin concomitantly with lovastatin. Therefore, patients receiving concomitant lovastatin and

erythromycin should be carefully monitored for creatine kinase (CK) and serum transaminase levels.

(See package insert for lovastatin.)

PRECAUTIONS

General

Prescribing Erythromycin Tablets in the absence of a proven or strongly suspected bacterial infection

or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the

development of drug-resistant bacteria.

Since erythromycin is principally excreted by the liver, caution should be exercised when erythromycin

is administered to patients with impaired hepatic function. (See CLINICAL PHARMACOLOGY and

WARNINGS.)

Exacerbation of symptoms of myasthenia gravis and new onset of symptoms of myasthenic syndrome has

been reported in patients receiving erythromycin therapy.

There have been reports of infantile hypertrophic pyloric stenosis (IHPS) occurring in infants

following erythromycin therapy. In one cohort of 157 newborns who were given erythromycin for

pertussis prophylaxis, seven neonates (5%) developed symptoms of non-bilious vomiting or irritability

with feeding and were subsequently diagnosed as having IHPS requiring surgical pyloromyotomy. A

possible dose-response effect was described with an absolute risk of IHPS of 5.1% for infants who

took erythromycin for 8 to 14 days and 10% for infants who took erythromycin for 15 to 21 days.

Since

erythromycin may be used in the treatment of conditions in infants which are associated with significant

mortality or morbidity (such as pertussis or neonatal Chlamydia trachomatis infections), the benefit of

erythromycin therapy needs to be weighed against the potential risk of developing IHPS. Parents should

be informed to contact their physician if vomiting or irritability with feeding occurs.

Prolonged or repeated use of erythromycin may result in an overgrowth of nonsusceptible bacteria or

fungi. If superinfection occurs, erythromycin should be discontinued and appropriate therapy instituted.

When indicated, incision and drainage or other surgical procedures should be performed in conjunction

with antibiotic therapy.

Observational studies in humans have reported cardiovascular malformations after exposure to drug

products containing erythromycin during early pregnancy.

Information for Patients

Patients should be counseled that antibacterial drugs including Erythromycin Tablets should only be

used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When

Erythromycin Tablets are prescribed to treat a bacterial infection, patients should be told that although it

is common to feel better early in the course of therapy, the medication should be taken exactly as

directed. Skipping doses or not completing the full course of therapy may (1) decrease the

effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop

resistance and will not be treatable by Erythromycin Tablets or other antibacterial drugs in the future.

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is

discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody

stools (with or without stomach cramps and fever) even as late as two or more months after having taken

the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

Drug Interactions

Theophylline

Erythromycin use in patients who are receiving high doses of theophylline may be associated with an

increase in serum theophylline levels and potential theophylline toxicity. In case of theophylline

toxicity and/or elevated serum theophylline levels, the dose of theophylline should be reduced while

the patient is receiving concomitant erythromycin therapy.

There have been published reports suggesting that when oral erythromycin is given concurrently with

theophylline there is a decrease in erythromycin serum concentrations of approximately 35%. The

mechanism by which this interaction occurs is unknown. The decrease in erythromycin concentrations

due to co-administration of theophylline could result in subtherapeutic concentrations of erythromycin.

Hypotension, bradyarrhythmias, and lactic acidosis have been observed in patients receiving concurrent

verapamil, belonging to the calcium channel blockers drug class.

Concomitant administration of erythromycin and digoxin has been reported to result in elevated digoxin

serum levels.

There have been reports of increased anticoagulant effects when erythromycin and oral anticoagulants

were used concomitantly. Increased anticoagulation effects due to interactions of erythromycin with

oral anticoagulants may be more pronounced in the elderly.

Erythromycin is a substrate and inhibitor of the 3A isoform subfamily of the cytochrome p450 enzyme

system (CYP3A). Coadministration of erythromycin and a drug primarily metabolized by CYP3A may be

associated with elevations in drug concentrations that could increase or prolong both the therapeutic

and adverse effects of the concomitant drug. Dosage adjustments may be considered, and when possible,

serum concentrations of drugs primarily metabolized by CYP3A should be monitored closely in patients

concurrently receiving erythromycin.

The following are examples of some clinically significant CYP3A based drug interactions. Interactions

with other drugs metabolized by the CYP3A isoform are also possible. The following CYP3A based

drug interactions have been observed with erythromycin products in post-marketing experience:

In addition, there have been reports of interactions of erythromycin with drugs not thought to be

metabolized by CYP3A, including hexobarbital, phenytoin, and valproate.

Erythromycin has been reported to significantly alter the metabolism of the nonsedating antihistamines

terfenadine and astemizole when taken concomitantly. Rare cases of serious cardiovascular adverse

events, including electrocardiographic QT/QT interval prolongation, cardiac arrest, torsades de

pointes, and other ventricular arrhythmias, have been observed. (See CONTRAINDICATIONS.) In

addition, deaths have been reported rarely with concomitant administration of terfenadine and

erythromycin.

Ergotamine/dihydroergotamine

Post-marketing reports indicate that co-administration of erythromycin with ergotamine or

dihydroergotamine has been associated with acute ergot toxicity characterized by vasospasm and

ischemia of the extremities and other tissues including the central nervous system. Concomitant

administration of erythromycin with ergotamine or dihydroergotamine is contraindicated (see

CONTRAINDICATIONS).

Triazolobenzodiazepines (such as triazolam and alprazolam) and related benzodiazepines

Erythromycin has been reported to decrease the clearance of triazolam and midazolam, and thus,

may increase the pharmacologic effect of these benzodiazepines.

HMG-CoA Reductase Inhibitors

Erythromycin has been reported to increase concentrations of HMG-CoA reductase inhibitors

(e.g., lovastatin and simvastatin). Rare reports of rhabdomyolysis have been reported in patients

taking these drugs concomitantly.

Sildenafil (Viagra)

Erythromycin has been reported to increase the systemic exposure (AUC) of sildenafil. Reduction

of sildenafil dosage should be considered. (See Viagra package insert.)

There have been spontaneous or published reports of CYP3A based interactions of erythromycin

with cyclosporine, carbamazepine, tacrolimus, alfentanil, disopyramide, rifabutin, quinidine,

methyl-prednisolone, cilostazol, vinblastine, and bromocriptine.

Concomitant administration of erythromycin with cisapride, pimozide, astemizole, or terfenadine is

contraindicated. (See CONTRAINDICATIONS.)

There have been post-marketing reports of drug interactions when erythromycin was co-administered

with cisapride, resulting in QT prolongation, cardiac arrhythmias, ventricular tachycardia, ventricular

fibrillation, and torsades de pointes, most likely due to the inhibition of hepatic metabolism of cisapride

by erythromycin. Fatalities have been reported. (See CONTRAINDICATIONS).

Colchicine

Colchicine is a substrate for both CYP3A4 and the efflux transporter P-glycoprotein (P-gp).

Erythromycin is considered a moderate inhibitor of CYP3A4. A significant increase in colchicine

plasma concentration is anticipated when co-administered with moderate CYP3A4 inhibitors such as

erythromycin. If co-administration of colchicine and erythromycin is necessary, the starting dose of

colchicine may need to be reduced, and the maximum colchicine dose should be lowered. Patients

should be monitored for clinical symptoms of colchicine toxicity (see WARNINGS).

Drug/Laboratory Test Interactions

Erythromycin interferes with the fluorometric determination of urinary catecholamines.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term oral dietary studies conducted with erythromycin stearate in rats up to 400 mg/kg/day and in

mice up to about 500 mg/kg/day (approximately 1 to 2 fold of the maximum human dose on a body

surface area basis) did not provide evidence of tumorigenicity. Erythromycin stearate did not show

genotoxic potential in the Ames, and mouse lymphoma assays or induce chromosomal aberrations in

CHO cells. There was no apparent effect on male or female fertility in rats treated with erythromycin

base by oral gavage at 700 mg/kg/day (approximately 3 times the maximum human dose on a body

surface area basis).

Pregnancy

Teratogenic Effects

Pregnancy Category B

There is no evidence of teratogenicity or any other adverse effect on reproduction in female rats fed

erythromycin base by oral gavage at 350 mg/kg/day (approximately twice the maximum recommended

human dose on a body surface area) prior to and during mating, during gestation, and through weaning.

No evidence of teratogenicity or embryotoxicity was observed when erythromycin base was given by

oral gavage to pregnant rats and mice at 700 mg/kg/day and to pregnant rabbits at 125 mg/kg/day

(approximately 1 to 3 times the maximum recommended human dose).

Labor and Delivery

The effect of erythromycin on labor and delivery is unknown.

Nursing Mothers

Erythromycin is excreted in human milk. Caution should be exercised when erythromycin is

administered to a nursing woman.

Pediatric Use

See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION.

Geriatric Use

Elderly patients, particularly those with reduced renal or hepatic function, may be at increased risk for

developing erythromycin-induced hearing loss. (See ADVERSE REACTIONS and DOSAGE AND

ADMINISTRATION).

Elderly patients may be more susceptible to development of torsades de pointes arrhythmias than

younger patients. (See WARNINGS.)

Elderly patients may experience increased effects of oral anticoagulant therapy while undergoing

treatment with erythromycin. (See PRECAUTIONS - Drug Interactions).

Erythromycin Tablets (250 mg) contain 8.5 mg (0.4 mEq) of sodium per tablet.

Erythromycin Tablets (500 mg) contain 17 mg (0.7 mEq) of sodium per tablet.

The geriatric population may respond with a blunted natriuresis to salt loading. This may be clinically

important with regard to such diseases as congestive heart failure.

ADVERSE REACTIONS

The most frequent side effects of oral erythromycin preparations are gastrointestinal and are dose-

related. They include nausea, vomiting, abdominal pain, diarrhea and anorexia. Symptoms of hepatitis,

hepatic dysfunction and/or abnormal liver function test results may occur. (See WARNINGS.)

Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment. (See

WARNINGS.)

Erythromycin has been associated with QT prolongation and ventricular arrhythmias, including

ventricular tachycardia and torsades de pointes. (See WARNINGS.)

Allergic reactions ranging from urticaria to anaphylaxis have occurred. Skin reactions ranging from

mild eruptions to erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis have

been reported rarely.

There have been reports of interstitial nephritis coincident with erythromycin use.

There have been rare reports of pancreatitis and convulsions.

There have been isolated reports of reversible hearing loss occurring chiefly in patients with renal

insufficiency and in patients receiving high doses of erythromycin.

OVERDOSAGE

In case of overdosage, erythromycin should be discontinued. Overdosage should be handled with the

prompt elimination of unabsorbed drug and all other appropriate measures should be instituted.

Erythromycin is not removed by peritoneal dialysis or hemodialysis.

DOSAGE AND ADMINISTRATION

In most patients, Erythromycin Tablets are well absorbed and may be dosed orally without regard to

meals. However, optimal blood levels are obtained when Erythromycin Tablets are given in the fasting

state (at least 1/2 hour and preferably 2 hours before meals).

Adults

The usual dosage of Erythromycin Tablets is one 250 mg tablet four times daily in equally spaced

doses or one 500 mg tablet every 12 hours. Dosage may be increased up to 4 g per day according to the

severity of the infection. However, twice-a-day dosing is not recommended when doses larger than 1 g

daily are administered.

Children

Age, weight, and severity of the infection are important factors in determining the proper dosage. The

usual dosage is 30 to 50 mg/kg/day, in equally divided doses. For more severe infections this dosage

may be doubled but should not exceed 4 g per day.

In the treatment of streptococcal infections of the upper respiratory tract (e.g., tonsillitis or pharyngitis),

the therapeutic dosage of erythromycin should be administered for at least ten days.

The American Heart Association suggests a dosage of 250 mg of erythromycin orally, twice a day in

long-term prophylaxis of streptococcal upper respiratory tract infections for the prevention of

recurring attacks of rheumatic fever in patients allergic to penicillin and sulfonamides.

Conjunctivitis of the Newborn Caused by Chlamydia trachomatis

Oral erythromycin suspension 50 mg/kg/day in 4 divided doses for at least 2 weeks.

Pneumonia of Infancy Caused by Chlamydia trachomatis

Although the optimal duration of therapy has not been established, the recommended therapy is oral

erythromycin suspension 50 mg/kg/day in 4 divided doses for at least 3 weeks.

Urogenital Infections During Pregnancy Due to Chlamydia trachomatis

Although the optimal dose and duration of therapy have not been established, the suggested treatment is

500 mg of erythromycin by mouth four times a day on an empty stomach for at least 7 days. For women

who cannot tolerate this regimen, a decreased dose of one erythromycin 500 mg tablet orally every 12

hours or 250 mg by mouth four times a day should be used for at least 14 days.

For adults with uncomplicated urethral, endocervical, or rectal infections caused by Chlamydia

trachomatis, when tetracycline is contraindicated or not tolerated

500 mg of erythromycin by mouth four times a day for at least 7 days.

For patients with nongonococcal urethritis caused by Ureaplasma urealyticum when tetracycline

is contraindicated or not tolerated

500 mg of erythromycin by mouth four times a day for at least seven days.

Primary syphilis

30 to 40 g given in divided doses over a period of 10 to 15 days.

Acute Pelvic Inflammatory Disease Caused by N. gonorrhoeae

500 mg Erythrocin

Lactobionate-I.V. (erythromycin lactobionate for injection, USP) every 6 hours for

3 days, followed by 500 mg of erythromycin base orally every 12 hours for 7 days.

Intestinal Amebiasis

Adults

500 mg every 12 hours or 250 mg every 6 hours for 10 to 14 days.

Children

30 to 50 mg/kg/day in divided doses for 10 to 14 days.

Pertus s is

Although optimal dosage and duration have not been established, doses of erythromycin utilized in

reported clinical studies were 40 to 50 mg/kg/day, given in divided doses for 5 to 14 days.

Legionnaires' Disease

Although optimal dosage has not been established, doses utilized in reported clinical data were 1 to 4 g

daily in divided doses.

HOW SUPPLIED

Erythromycin Tablets are supplied as pink, unscored oval tablets in the following strengths and

packages.

NDC 69189-0112-1 single dose pack with 1 tablet as repackaged by Avera McKennan Hospital

250 mg tablets (debossed

with EB):

Bottles of 100

(NDC 24338-102-13)

Recommended storage

Store below 86??F (30??C).

REFERENCES

1. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility

Tests for Bacteria that Grow Aerobically, Approved Standard ??? Ninth Edition. CLSI document M07-

A9, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne,

Pennsylvania 19087, USA, 2012.

2. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial

Susceptibility Testing: Twenty-third Informational Supplement. CLSI document M100-S23, Clinical and

Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087,

USA, 2013.

3. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk

Diffusion Susceptibility Tests; Approved Standard ??? Eleventh Edition CLSI document M02-A11.

Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania

19087, USA, 2012.

4. Committee on Rheumatic Fever, Endocarditis, and Kawasaki Disease of the Council on

Cardiovascular Disease in the Young, the American Heart Association: Prevention of Rheumatic

Fever. Circulation. 78(4):1082-1086, October 1988.

5. Honein, M.A., et. al.: Infantile hypertrophic pyloric stenosis after pertussis prophylaxis with

erythromycin: a case review and cohort study. The Lancet 1999:354 (9196): 2101-5.

6. Data on file, Arbor Pharmaceuticals, LLC.

03-A922-R2 Revised: July, 2013

Arbor Pharmaceuticals, LLC

Atlanta, GA 30328

(Nos. 6326 and 6227)

PRINCIPAL DISPLAY PANEL - 250 mg label

ERYTHROMYCIN

erythromycin tablet, film coated

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 9 18 9 -0 112(NDC:24338 -10 2)

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Erythro mycin (UNII: 6 39 37KV33D) (Erythro mycin - UNII:6 39 37KV33D)

Erythro myc in

250 mg

Inactive Ingredients

Ingredient Name

Stre ng th

Silico n Dio xide (UNII: ETJ7Z6 XBU4)

cro sca rmello se so dium (UNII: M28 OL1HH48 )

cro spo vido ne (UNII: 6 8 40 19 6 0 MK)

D&C Red No . 3 0 (UNII: 2S42T28 0 8 B)

a luminum o xide (UNII: LMI26 O6 9 33)

hydro xypro pyl cellulo se ( type H) (UNII: RFW2ET6 71P)

hypro mello ses (UNII: 3NXW29 V3WO)

hypro mello se phtha la te ( 2 4 % phtha la te, 55 CST) (UNII: 8 7Y6 436 BKR)

ma g nesium stea ra te (UNII: 70 0 9 7M6 I30 )

cellulo se, micro crysta lline (UNII: OP1R32D6 1U)

po vido nes (UNII: FZ9 8 9 GH9 4E)

po lyethylene g lyco ls (UNII: 3WJQ0 SDW1A)

Avera McKennan Hospital

po lyethylene g lyco ls (UNII: 3WJQ0 SDW1A)

pro pylene g lyco l (UNII: 6 DC9 Q16 7V3)

so dium citra te (UNII: 1Q73Q2JULR)

so dium hydro xide (UNII: 55X0 4QC32I)

so rbic a cid (UNII: X0 45WJ9 8 9 B)

so rbita n mo no o lea te (UNII: 0 6 XEA2VD56 )

ta lc (UNII: 7SEV7J4R1U)

tita nium dio xide (UNII: 15FIX9 V2JP)

Product Characteristics

Color

PINK

S core

no sco re

S hap e

OVAL

S iz e

15mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 9 18 9 -0 112-1

1 in 1 DOSE PACK; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 6 16 21

0 3/0 1/20 15

Labeler -

Avera McKennan Hospital (068647668)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Avera McKennan Ho spital

0 6 8 6 476 6 8

relabel(6 9 18 9 -0 112) , repack(6 9 18 9 -0 112)

Revised: 11/2015

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